DUPEN LONG TERM EPIDURAL CATHETER
FDA premarket approval P860064/S009 · decided 1998-01-26
Approval details
- PMA number
- P860064
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DUPEN LONG TERM EPIDURAL CATHETER
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- C.R. Bard, Inc.
- Date received
- 1998-01-15
- Decision date
- 1998-01-26
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Salt Lake Ciy,, UT
- Statement
- Approval for modifications to the instructions for use (IFU) for the DuPen Long Term Epidural Catheter and the DuPen Catheter Repair Kit. These six modifications are: 1) to delete references to resterilization of product; 2) to add a caution to the Repair Kit IFU to examine the package and not use or resterilize if package is damaged; 3) to add the prescription statement to the Repair Kit IFU; 4) To add international units of measurea nd general international requirements; 5) To add a general bi
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